Surgical stapling apparatus

ABSTRACT

A surgical stapling apparatus is provided and includes a housing having an actuator; an elongated member extending from the housing; an end effector disposed on an end of the elongated member, the end effector having a first jaw and a second jaw, the first jaw having a staple cartridge and the second jaw having a plurality of staple forming recesses; the staple cartridge having at least a first segment and a second segment, the first segment and the second segment each having a tissue contacting surface and staple receiving slots defined in the tissue contacting surface, the first segment and the second segment being biased toward the second jaw and movable; a biasing members for each of the first segment and the second segment; and a pressure sensor for each of the first segment and the second segment.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a Continuation application of U.S. patentapplication Ser. No. 13/598,696, filed on Aug. 30, 2012, which is aContinuation application of U.S. patent application Ser. No. 13/025,262,filed on Feb. 11, 2011, now U.S. Pat. No. 8,276,801, which is aContinuation-in-Part application claiming the benefit of and priority toU.S. patent application Ser. No. 13/018,467, filed on Feb. 1, 2011, nowabandoned, which is a Continuation-in-Part application claiming thebenefit of and priority to U.S. patent application Ser. No. 12/796,270,filed on Jun. 8, 2010, now U.S. Pat. No. 8,360,299, which claims thebenefit of and priority to U.S. Provisional Patent Application Ser. No.61/232,826, filed on Aug. 11, 2009, the entire contents of each of whichare incorporated herein by reference.

BACKGROUND

1. Technical Field

The present disclosure relates to surgical stapling apparatuses that arecapable of applying lines of fasteners to tissue while cutting thetissue between those fastener lines and, more particularly, toimprovements relating to fastener deployment and formation.

2. Background of Related Art

Endoscopic and laparoscopic surgical apparatuses are often preferredover traditional open surgical devices since a smaller incision tends toreduce the post-operative recovery time and complications. The use oflaparoscopic and endoscopic surgical procedures has been relativelypopular and has provided additional incentive to develop the proceduresfurther. In laparoscopic procedures, surgery is performed in theinterior of the abdomen through a small incision. Similarly, inendoscopic procedures, surgery is performed in any hollow viscus of thebody through narrow endoscopic tubes inserted through small entrancewounds in the skin.

Laparoscopic and endoscopic procedures generally require that thesurgical region be insufflated. Accordingly, any instrumentationinserted into the body must be sealed to ensure that gases do not enteror exit the body through the incision. Moreover, laparoscopic andendoscopic procedures often require the surgeon to access organs,tissues and/or vessels far removed from the incision. Thus, apparatusesused in such procedures are typically long and narrow while beingfunctionally controllable from a proximal end of the apparatus.

Significant development has gone into a range of endoscopic surgicalapparatuses that are suitable for precise placement of a distal endeffector at a desired surgical site through a cannula of a trocar. Thesedistal end effectors engage the tissue in a number of ways to achieve adiagnostic or therapeutic effect (e.g., endocutter, grasper, cutter,staplers, clip applier, access device, drug/gene therapy deliverydevice, and energy device using ultrasound, RF, laser, etc.).

Known surgical stapling apparatuses include an end effector that makes alongitudinal incision in tissue and subsequently applies lines offasteners on opposing sides of the incision. The end effector includes apair of cooperating jaws that, if the apparatus is intended forendoscopic or laparoscopic applications, are capable of passing througha cannula passageway. One of the jaws receives a fastener cartridgehaving at least two laterally spaced rows of fasteners. The other jawdefines an anvil having fastener-forming pockets aligned with the rowsof fasteners in the cartridge. The apparatus includes a plurality ofreciprocating wedges or cam bars which, when driven distally, passthrough openings in the fastener cartridge and engage drivers supportingthe fasteners to effect the firing of the fasteners toward the anvil.

Small videoscopes of various types (e.g., endoscopes) may be relied uponto monitor proper positioning and operation of the surgical staplingapparatus. While effective to a degree, it is desirable to have improvedmonitoring of operation of the surgical stapling apparatus. Whenutilizing stapling devices containing multiple fasteners in eachcartridge load, it is also beneficial to determine which fasteners arebeing deployed and whether they are being formed properly.

Consequently, a continuing need exists for an improved surgical staplingand severing apparatus that incorporates fastener deployment andformation pressure monitoring capabilities to assure the mechanical andhemostatic integrity of a surgical stapling device.

SUMMARY

In accordance with the present disclosure, a surgical stapling apparatusis disclosed. The surgical stapling apparatus has a housing having anactuator; an elongated member extending from the housing; an endeffector disposed on one end of the elongated member, the end effectorincluding first and second jaws; a plurality of fasteners disposed inthe end effector; a plurality of pusher members located in the endeffector, each pusher member in the plurality of pusher membersoperatively coupled to a number of fasteners; an actuation mechanismoperatively coupled to the actuator, the actuation mechanism including alongitudinally translatable drive member and an actuation sled coupledthereto, the actuation sled configured for engaging the plurality ofpusher members; and a pressure responsive element disposed in one of thejaws, the pressure responsive element communicating a signal to acontroller coupled to the surgical stapling apparatus, the signalrepresentative of pressure applied to the pressure responsive element.

In one embodiment, interaction between the actuation sled and the pushermembers applies pressure to the pressure responsive element. Thepressure responsive element includes staggered pressure sensors in acircuit. The circuit, in some manifestations is a printed pressurecircuit or a flexible circuit disposed on the surface of a channelpositioned in one of the jaws.

In another embodiment, the surgical stapling apparatus can include acircuit that is disposed on the external surface of at least one of thejaws. In this version, the stapling apparatus also includes a beam, thebeam disposed on the external surface of at least one of the jaws andseated in a groove disposed within at least one of the jaws so that thebeam can be configured to translate along the groove. The beam may be anI-beam or an E-beam.

The circuit can have a laminate layer on the circuit and may even have alubricant coating on the laminate layer. The signal communicated to thecontroller will from time to time be read by the controller asirregular. In such a case, the controller will activate a feedbackresponse such as an error code, warning, or it may even stop fastenerdeployment altogether. It is contemplated that the pressure responsiveelement communicates the signal to the controller through by any of thefollowing: voltage, resistance, impedance, electromagnetism, radiofrequency, current, inductance, capacitance, infrared, optics, or anycombination thereof.

Another embodiment envisions a knife configured to translate through thejaw to cut tissue. However, upon certain predetermined irregularities,the controller can prevent the knife from cutting, should thoseirregularities fall within those predetermined conditions. An encoder isconfigured to recognize irregular component positions relative to thepressure applied and send a signal to the controller. The encoder may beconfigured to recognize irregular positions of various componentsincluding the actuation mechanism, the knife, the actuator, theactuation sled, the pusher member, the first jaw, the second jaw, oreven various combinations thereof. These encoders can be linear orrotational.

Certain embodiments contemplate the circuit including a cartridgeidentifying feature. Other embodiments can have controller configured toset positional limitations and run mode for a particular load orfastener type. Still further, one of the jaws may be configured anddimensioned to house a non-linear cartridge.

In other embodiments, the controller includes an end user feedbackcommunication feature. The end user feedback communication feature isconfigured to communicate the feedback to an end user through percipientsignals such as audible, visual, tactile, or any combination thereof.

According to another aspect of the present disclosure, a surgicalstapling apparatus is provided and includes a housing having anactuator; an elongated member extending from the housing; an endeffector disposed on an end of the elongated member, the end effectorhaving a first jaw and a second jaw, the first jaw having a staplecartridge and the second jaw having a plurality of staple formingrecesses; the staple cartridge having at least a first segment and asecond segment, the first segment and the second segment each having atissue contacting surface and staple receiving slots defined in thetissue contacting surface, the first segment and the second segmentbeing biased toward the second jaw and movable; a biasing members foreach of the first segment and the second segment; and a pressure sensorfor each of the first segment and the second segment.

The surgical stapling apparatus may further include a component fordetermining when the pressure is above a threshold value.

The surgical stapling apparatus may further include a motor operativelyconnected to the actuator. The motor may be in the housing.

The surgical stapling apparatus may further include a power source inthe housing and operatively connected to the motor.

The component may be programmed to stop the motor.

The staple forming recesses and the staple receiving slots may definelinear rows. The linear rows may extend transversely with respect to alongitudinal axis of the elongated member. The staple forming recessesand the staple receiving slots may define an angle with respect to alongitudinal axis of the end effector.

According to a further aspect of the present disclosure, an end effectorfor selective connection to a surgical apparatus, is provided andincludes a first jaw; a staple cartridge supported on the first jaw, thestaple cartridge defining a tissue contacting surface, wherein thestaple cartridge is divided into a plurality of independent, separatelymovable segments, and at least one staple retaining slot is defined ineach segment; a second jaw connected to the first jaw, the second jawsupporting an anvil, the anvil defining a plurality of staple formingrecesses arranged in juxtaposed correspondence with the plurality ofstaple retaining slots of the staple cartridge; and a pressure sensingelement interposed between each staple cartridge segment and the firstjaw, wherein each pressure sensing element senses a force exerted oneach respective staple cartridge segment.

The end effector may further include a biasing member interposed betweeneach staple cartridge segment and the first jaw. The biasing members maymaintain each staple cartridge segment spaced a distance from the firstjaw.

The staple cartridge may define at least two parallel rows of stapleretaining slots. At least one substantially adjacent staple retainingslot from each row of staple retaining slots may be provided in eachstaple cartridge segment.

The biasing members may compress upon exertion of a force on the tissuecontacting surface of any of the staple cartridge segments.

According to still another aspect of the present disclosure, anelectro-surgical stapling system is provided and includes a poweredsurgical apparatus and an end effector. The powered surgical apparatusincludes a handle portion configured and adapted to releasably connect asurgical stapling end effector thereto, the handle portion including anactuator for connection to the end effector and for driving the endeffector, a motor for driving the actuator, a power source for poweringthe motor, and a controller for controlling at least one of the powersource and the motor. The end effector is configured for selectiveconnection to the handle portion of the powered surgical apparatus. Theend effector includes a first jaw; a staple cartridge supported on thefirst jaw, the staple cartridge defining a tissue contacting surface,wherein the staple cartridge is divided into a plurality of independent,separately movable segments, and at least one staple retaining slot isdefined in each segment; a second jaw connected to the first jaw, thesecond jaw supporting an anvil, the anvil defining a plurality of stapleforming recesses arranged in juxtaposed correspondence with theplurality of staple retaining slots of the staple cartridge; and apressure sensing element interposed between each staple cartridgesegment and the first jaw, wherein each pressure sensing element sensesa force exerted on each respective staple cartridge segment. Eachpressure sensing element is in electrical communication with thecontroller. The controller stops at least one of approximation of thefirst jaw and the second jaw, and firing of the powered surgicalapparatus when a force exerted on at least one of the staple cartridgesegments and sensed by the respective pressure sensing elements exceedsa predetermined threshold force.

The end effector may further include a biasing member interposed betweeneach staple cartridge segment and the first jaw. The biasing members maymaintain each staple cartridge segment spaced a distance from the firstjaw.

The staple cartridge of the end effector may define at least twoparallel rows of staple retaining slots. At least one substantiallyadjacent staple retaining slot from each row of staple retaining slotsmay be provided in each staple cartridge segment.

The biasing members of the end effector may compress upon exertion of aforce on the tissue contacting surface of any of the staple cartridgesegments.

The first jaw and the second jaw of the end effector may be configuredfor parallel approximation.

BRIEF DESCRIPTION OF THE DRAWINGS

The above and other aspects, features, and advantages of the presentdisclosure will become more apparent in light of the following detaileddescription when taken in conjunction with the accompanying drawings inwhich:

FIG. 1A is a perspective view of a powered surgical stapling apparatus;

FIG. 1B is a perspective view of a manual surgical stapling apparatus;

FIG. 1C is an enlarged perspective view of the end effector of asurgical stapling apparatus;

FIG. 1D is a perspective view of the end effector during a fastenerapplying operation as the wedge translates through the cartridge tosequentially eject the fasteners from the cartridge and drive themagainst one of the jaws to be formed thereby;

FIG. 2 is a schematic view of a surgical stapling system in accordancewith the present disclosure;

FIG. 3A is a side cross-sectional view of a portion of the end effectorof the surgical stapling apparatus' of FIGS. 1A and 1B;

FIG. 3B is a side cross-sectional view of a portion of the end effectorof the surgical stapling apparatus' of FIGS. 1A and 1B with a cartridgewall removed for clarity;

FIG. 4A is a side elevational view of the surgical stapling apparatus ofFIG. 1B with the housing sectioned to illustrate the actuation mechanismwhen the actuator is manipulated through one an actuation stroke toapply a portion of the fasteners from the cartridge to tissue;

FIG. 4B is a perspective view in partial cross-section of the surgicalstapling apparatus of FIG. 4A in accordance with the present disclosure;

FIG. 5 is a plot of the pressure applied to form staples versus time;

FIG. 6 is a perspective view of the interior channel of the cartridgewith a printed pressure circuit disposed therein;

FIG. 7 is a perspective view of a removable end effector of FIGS. 1A and1B illustrating a knife slot in one of the jaws;

FIG. 8A is a perspective view of the end effector of FIG. 7 with theanvil cover removed for clarity showing a pressure circuit;

FIG. 8B is an enlarged perspective view of the embodiment disclosed inFIG. 8A;

FIG. 9 is a schematic view of the end user feedback communicationfeature according to one embodiment of the present disclosure;

FIG. 10 is a schematic view of the cartridge identifying featureaccording to one embodiment of the present disclosure;

FIG. 11 is a schematic of the encoder feature according to oneembodiment of the present disclosure;

FIG. 12 is a perspective view of a surgical device or end effector for apowered surgical stapling apparatus according to another embodiment ofthe present disclosure;

FIG. 13 is an exploded perspective view of the surgical device or endeffector of FIG. 12;

FIG. 14 is an enlarged perspective view illustrating a staple guidesupported in a staple cartridge frame housing of the surgical device orend effector of FIG. 12;

FIG. 15 is an enlarged perspective view of the staple guide of thesurgical device or end effector of FIG. 12; and

FIG. 16 is a cross-sectional view of the surgical device or end effectorof FIG. 12, as taken through 16-16 of FIG. 12.

DETAILED DESCRIPTION OF EMBODIMENTS

Embodiments of the presently disclosed surgical stapling apparatus willnow be described in detail with reference to the drawings, in which likereference numerals designate identical or corresponding elements in eachof the several views.

As shown in the drawings and as described throughout the followingdescription, and as is traditional when referring to relativepositioning on an object, the term “proximal” refers to the end of theapparatus that is closer to the user and the term “distal” refers to theend of the apparatus that is further from the user. In the followingdescription, well-known functions or constructions are not described indetail to avoid obscuring the present disclosure in unnecessary detail.

FIG. 1A illustrates a powered surgical stapling apparatus showngenerally as 100. FIG. 1B illustrates a manual surgical staplingapparatus shown generally as 200. Briefly, the surgical staplingapparatus 100, 200 includes a housing 102 having an actuator 136, anelongated member 104 extending from the housing 102, and an end effector106 disposed on one end of the elongated member 104. As shown in FIG. 1,the housing 102 supports a motor 102 a, a power source 102 b (e.g., abattery), and a controller 120 therein that are operatively coupledtogether and to the actuator 136 for firing fasteners supported in theend effector 106 as described in greater detail hereinbelow. From FIGS.1C-1D, the end effector 106 includes first and second jaws 108, 110, aplurality of fasteners 114 (e.g., staples) disposed in the end effector106 and a plurality of pusher members 130 located in the end effector106. Each pusher member 130 in the plurality of pusher members 130 isoperatively coupled to a number of fasteners 114. As seen in FIGS.3A-4B, the surgical stapling apparatus 100, 200 includes an actuationmechanism 138 operatively coupled to the actuator 136. The actuationmechanism 138 includes a longitudinally translatable drive member 140and an actuation sled 132 coupled thereto. The actuation sled 132 isconfigured for engaging the plurality of pusher members 130.

In accordance with one embodiment of the present disclosure, FIG. 2diagrams a surgical stapling system having a surgical stapling apparatus100, 200, the surgical stapling apparatus 100, 200 having a pressureresponsive element 150 and the controller 120. It is envisioned that thepressure responsive element is disposed in one of the jaws 108, 110(FIGS. 3A-3B and 8A-8B). The pressure responsive element 150 cancommunicate a pressure signal 152 (not shown) to the controller 120coupled to the surgical stapling apparatus 100, 200. The controller 120is a microcontroller or an analog circuit which enables control,positioning, status, and fastener 114 quality feedback. The pressuresignal 152 is representative of pressure applied to the pressureresponsive element 150. It is envisioned that this embodiment mayinclude a knife 164 or be knifeless, the knife 164 slidably translatablethrough a knife slot 174 (FIG. 1C).

Referring to FIG. 5, applied pressure may be measured in the form ofwaveform pulsations as seen in the time versus applied pressure graph.For example, a normal sample might read in accordance with the graphcovering the time period from 0-t1. If the waveform pulsations indicatea low (t2-t3) or high (t1-t2) pressure during a certain sampling, thiscould be an indication that the fasteners 114 are not being properlydeployed or formed due to improper applied pressure distributionnecessary for proper fastener 114 deployment or formation.Alternatively, if the waveform is not a shape that has been correlatedwith successful test waveforms (t3-t4), an error code or feedback isinitiated by the controller 120 to stop deployment or formationprogression. This gives the end user the ability to properly understandthe performance irregularity before proceeding or backing out.

As seen in FIGS. 3A-3B, the first jaw 108 includes a cartridge channel128 for receiving a cartridge 112. The cartridge 112 includes aplurality of fasteners 114 disposed therein. Typically, fasteners 114are in the form of a plurality of surgical staples. The cartridge 112houses the fasteners 114 in a plurality of linear rows, which areoperatively coupled to the pusher members 130.

Referring now to FIG. 6, the pressure responsive element 150 of onemanifestation includes a circuit 124 wherein at least one lead 154connects at least one pressure sensor 126. It is also contemplated thata plurality of pressure sensors 126 are disposed on the surgicalstapling apparatus 100, 200. In one instance, a lead 154 extends acrossa plurality of pressure sensors 126 in linear progression along thelongitudinal axis, wherein at least one pressure sensor 126 correspondsto each fastener 114 or pusher member 130. Each linear row of fasteners114 and/or pusher members 130 is connected by at least one lead 154extending along the linear row and along the longitudinal axis of thecircuit 124. The circuit 124 is a flexible or a printed pressure circuit124.

In this embodiment, the circuit 124 is adhered to the top (working)surface of the cartridge channel 128 so that the circuit 124 caninteract with the actuation sled 132 that translates therethrough. Inother words, the circuit 124 is disposed within the cartridge channel128 to matingly engage the actuation sled 132 as the actuation sled 132translates through the cartridge channel 128 (FIGS. 3A-3B).

FIGS. 7-8B show another embodiment of the surgical stapling apparatus100, 200. As seen in FIGS. 8A-8B, the surgical stapling apparatus 100,200 includes a pressure responsive element 150 that includes a circuit124 and is disposed on the external surface of at least one of the jaws108, 110. Preferably, the circuit 124 is disposed on the externalsurface of the second jaw 110. This embodiment includes a beam 162. Thebeam 162 is disposed on the external surface of at least one of the jaws108, 110. Preferably, the beam 162 is disposed on the external surfaceof the second jaw 110. It is also contemplated that the beam 162 isslidably seated in a groove 116 disposed within at least one of the jaws108, 110 and connected to the actuation sled 132 (FIGS. 8A and 8B). Thebeam 162 is slidably seated in a groove 116 disposed within the secondjaw 110. The beam 162 is configured to translate along the groove 116.The beam is an I-beam or an E-beam. This circuit 112 is envisioned to bevery thin with respect to the surgical stapling apparatus 100, 200,having dimensions at least geometrically thin enough as to notcompromise or greatly impact the overall cartridge 112 size or function.

In some manifestations, the pressure sensors 126 are staggered (FIGS.3B, 6, 8A, 8B). The circuit 124 in one arrangement is staggered andoptimized so that detailed information can be obtained for each fastener114 or group of fasteners 114 formed by their associated pusher member130. By having the pressure sensors 126 staggered from the proximal todistal positions relative to the fasteners 114 within the surgicalstapling apparatus 100, 200, the surgical stapling apparatus 100, 200can be configured to determine deployment timing and completion of eachfastener 114. This is valuable for controlling the surgical staplingapparatus 100, 200 with a controller 120 to verify limits with eachspecific cartridge 112 for clamping, distal stop, or home position. Thecontroller 120 may have an analog or a microelectronic circuit.

As fastener 114 progression unfolds, the pressure responsive element 150communicates a pressure signal 152 to the controller 120 through atleast one communication means selected from the group comprisingvoltage, resistance, impedance, electromagnetism, radio frequency,current, inductance, capacitance, infrared, and optics. In operation,the pressure responsive element 150 tracks the applied pressure as thefasteners 114 are deployed and formed in progression (FIG. 5). In somecases, the applied pressure can be tracked in the form of waveformpulsations. When the controller 120 recognizes irregular pressurepatterns represented by the pressure signal 152 communicated from thepressure responsive element 150, the controller 120 correspondinglyregisters an error and may be configured to emit an error code, emit awarning, stop fastener 114 formations, or even stop fastener 114deployments.

The pressure responsive element 150 may also be configured for bothlinear and non-linear cartridge 112 configurations. It is envisionedthat at least one of the jaws 108, 110, preferably the first jaw 108,includes a non-linear cartridge. In other words, the pressure responsiveelement 150 can be used for linear cartridge 112 surgical staplingapparatuses 100, 200 or non-linear cartridge 112 surgical staplingapparatuses 100, 200 including curved, circular, or any othergeometrically-shaped cartridge 112 required to assess fastener qualityor progression status.

Often, the surgical stapling apparatus 100, 200 can include a knife 164.In one manifestation of the present disclosure, the surgical staplingapparatus 100, 200 is configured and dimensioned such that thecontroller 120 prevents the knife 164 from cutting. In other words, thecontroller 120 includes an encoder 166, i.e., a knife cutting preventionfeature. As seen in FIG. 11, one configuration contemplates the encoder166 configured to recognize irregular behaviour of the surgical staplingapparatus 100, 200. In some instances, the encoder 166 is configured anddimensioned to recognize component positions relative to the pressureapplied. The components of which are selected from the group comprisingthe actuation mechanism 138, knife 164, actuator 136, actuation sled132, pusher member 130, first jaw 108, and second jaw 110, or anycombination thereof. The encoder 166 can be rotational, or even linear.

Referring to FIG. 9, the controller 120, in some manifestations,includes an end user feedback communication feature 170. The end userfeedback communication feature 170 is configured to communicate feedbackto an end user after receiving and deciphering a signal 152, 191 throughat least one means selected from the group comprising audible (bells,speech, buzzers, beeps, etc.), visual (lights, LED's, LCD, orelectroluminescent screens of varying colors, text, and/or symbols), andtactile (vibratory). For example, the feedback may be configured toindicate the successful or unsuccessful completion of a task such asinitiation of fastener deployment progression, completion of fastenerdeployment and formation, individual fastener deployment, individualfastener formation, or other similar tasks recognized by a person ofordinary skill in the art.

To protect the circuit 124 from tearing or abrasion and to attainaccurate, repeatable feedback, a thin, hard surface material such asKapton® polyimide film or a foil of titanium or steel alloy or a flashcoated nickel, chrome or nitride coating can be laminated onto the toplayer of the circuit 124, defining a laminate 158. Furthermore, alubricant coating 160 may also be applied to the laminate layer. Thelubricant coating 160 is any low friction plastic, grease, PTFE blendedmaterial, or any other comparable lubricant. The lubricant 160 isbeneficial for achieving a quality output pressure signal 152 and forimproving the robustness of working components.

As seen in FIG. 10, the surgical stapling apparatus 100, 200 may have acircuit 124 including a cartridge identifying feature 168. Inparticular, the pressure responsive element 150 includes at least onecircuit 124, wherein each circuit 124 has a specific electrical range orvalue of resistance, inductance, or impedance that can be read by thecontroller 120 to determine the exact type of cartridge 112 or endeffector 106 loaded for identification. With this feature, the surgicalstapling apparatus 100, 200 includes a controller 120 configured to setcartridge 112 or fastener 114 specific positional limitations and/or runmode.

In operation, when an end user (not shown) actuates the actuator 136,the actuating mechanism 138 causes the actuation sled 132 to interactwith the pusher members 130 (FIG. 4A). In certain variations, theactuator 136 includes separate actuating features for actuating theactuation sled 132 and the first and second jaws 108, 110. For example,an actuation sled actuator 136 a is used to remotely actuate theactuation sled 132, and a jaw actuator 136 b is used to actuate firstand second jaws 108, 110. Alternatively, a single actuator 136 is usedto actuate both the actuation sled 132 and the jaws 108, 110. In anotherexample, separate actuators 136 are connected to the individual firstand second jaws 108, 110.

Upon actuation, the actuation sled 132 wedges the pusher members 130upwards, forcing the fasteners 114 up into the opposing second jaw 110surface, and in particular, into fastener-forming pockets 156 (FIG. 1D).From FIG. 1D, in its initial configuration the fastener 114 is shaped ina substantially U-shaped configuration. In its fully formedconfiguration, the faster 114 is shaped in a substantially B-shapedconfiguration. In the process of transforming the fastener 114 from thefirst configuration to the second configuration, the second jaw 110 actsas an anvil and correspondingly compresses the fastener 114 into itssecond configuration B-shape as the fastener prongs 114 a, 114 b engagethe fastener-forming pockets 156. This resulting pressure applied to thepressure responsive element 150 is therefore a result of the interactionbetween the actuation sled 132 and the pusher members 130.

In embodiments where the pressure responsive element 150 includes acircuit 112 disposed within the cartridge channel 128, the downwardforce of the second jaw 110 onto the upwardly driving fastener 114,pusher member 130, and actuation sled 132 combination consequentlycauses reaction forces to pass through fasteners 114, pusher member 130,and actuation sled 132 combination in the opposing downward directionand onto the circuit 112 and any pressure sensors 126, whichcorrespondingly register the applied pressure. The pressure responsiveelement 150 then communicates a pressure signal 152 to the controller120, where the pressure signal 152 is representative of the pressureapplied to the pressure responsive element 152. The controller 120receives the pressure signal 152 and selectively emits a response orfeedback based on the pressure signal 152.

In certain embodiments, the pressure responsive element 150 includes acircuit 112 disposed on the external surface of one of the jaws 108,110. For example, when the circuit 112 is disposed on the externalsurface of the second jaw 110, applied pressure is displaced from thebeam 162, which is connected to the actuation sled 132, onto the circuit112 as both the beam 162 and the actuation sled 132 translatelongitudinally along the first and second jaws 108, 110. In other words,as the actuation sled 132 translates and engages the pusher members 130,the pusher members 130 drive fasteners 114 up into the second jaw 110and fastener-forming pockets 156. This consequently causes downwardreaction forces to be displaced to the beam 162 onto the circuit 112 asthe actuation sled 132 pulls down the beam 162 from the resultantdownward reaction forces from the fastener-forming pockets 156 passthrough the fasteners 114 and pusher members 130 onto the actuation sled132. The pressure sensors 126 correspondingly register the appliedpressure. The pressure responsive element 150 than communicates apressure signal 152 to the controller 120, where the pressure signal 152is representative of the pressure applied to the pressure responsiveelement 152. The controller 120 receives the pressure signal 152 andselectively emits a response or feedback based on the pressure signal152.

In embodiments that include an encoder 166, the encoder 166 isconfigured to recognize the irregular behaviour of a component of thesurgical stapling apparatus 100, 200 the components of which can beselected from the group comprising the actuation mechanism 138, knife164, actuator 136, actuation sled 132, pusher member 130, first jaw 108,and second jaw 110. In one example where the encoder 166 is configuredto monitor the positions of the knife 164, and where the encoder 166recognizes an irregular position of the knife 164, the encoder 166communicates the irregularity to the controller 120 via an encodersignal 191, the signal either regular 191 a or irregular 191 b. Uponreceiving an irregular signal 191 b, the controller 120 registers anerror code, and in some instances, is configured to prevent cuttingwithout fastening.

The encoder 166 communicates the encoder signal 191 to the controller120 through at least one means selected from the group comprisingvoltage, resistance, impedance, electromagnetism, radio frequency,current, inductance, capacitance, infrared, and optics. It is alsoenvisioned that the controller 120 is configured and dimensioned toreceive an encoder signal 191 from the pressure responsive element 150and to determine fastener 114 deployment and formation disparities withrespect to the component behaviour, e.g., the knife's 164 irregularpositioning. The controller 120 is also configured and dimensioned toinitiate an error code or modify fastener 114 deployment settings.

Turning now to FIGS. 12-16, a surgical device or end effector, for apowered surgical stapling apparatus according to another embodiment ofthe present disclosure, is shown and generally designated 500. Endeffector 500 includes a parallel separating jaw system wherein opposingjaws remain parallel relative to each other during approximation andseparation. End effector 500 is configured to be capable of connectionto powered, rotating drive shafts of an electro-mechanical power source(not shown).

As seen in FIGS. 12 and 13, end effector 500 includes a first jaw 580and a second jaw 550, wherein the first jaw 580 and the second jaw 550are in contact with each other at their respective first ends so as toenable parallel approximation and separation.

As seen in FIG. 13, the second jaw 550 includes an anvil 505 having avertically-disposed, internally-threaded bore 5051 at its upper end5052, and a plurality of staple guides 5053 arranged in parallel rowsalong a region 5054 of the anvil 505 that is opposite to, andcorresponds to, the first jaw 580.

With continued reference to FIG. 13, first jaw 580 includes a housingframe 506 defining a pair of internally disposed guides 5061 along whicha pair of ribs 5055 of the anvil 505 of second jaw 550 may travel, sothat the housing frame 506 may move toward and away from the anvil 505while remaining parallel with the anvil 505.

A gear housing 255 is mounted to one side 5062 of the housing frame 506.A quick-connect coupling 511 is mounted onto the gear housing 255. Amemory module 501 is arranged in the gear housing 255 and includes aconnector 2554 that extends through, or is accessible through, anopening 2553 of the gear housing 255. The memory module 501 ismaintained in position within the gear housing 255 by an inboard shim530 and an outboard shim 531. The gear housing 255 includes a firstdrive socket 180 and a second drive socket 310. In this embodiment, thefirst drive socket 180 of the gear housing 255 includes a first pinion508 a, and the second drive socket 310 of the gear housing 255 includesa second pinion 508 b.

Each of the first and second pinions 508 a and 508 b engage respectivefirst and second spur gears 529 a and 529 b. The first spur gear 529 anon-rotatably engages a first worm 523 a. The second spur gear 529 bnon-rotatably engages a second worm 523 b. A threaded portion of each ofthe first worm 523 a and the second worm 523 b is disposed within theframe housing 506.

Also disposed within the frame housing 506 is a gear 522 whichthreadably engages the threaded portion of the first worm 523 a. Thegear 522 non-rotatably engages a screw 521. The screw includesexternally-disposed threads 5214, which engage the internally-threadedbore 5051 of the anvil 505.

A first gear 516 and a second gear 517 are disposed within the framehousing 506. The first gear 516 and the second gear 517 are positionedon opposite sides of and engaged with the second worm 523 b.Specifically, the first gear 516 engages a first side of the second worm523 b, and the second gear 517 engages a second side of the second worm523 b.

An externally-threaded screw 504 is disposed through aninternally-threaded bore 5164 of the first gear 516, and anexternally-threaded screw 503 is disposed through an internally-threadedbore 5174 of second gear 517. Since the first and second gears 516 and517 are located on, and engage, opposite sides of the second worm 523 b,the internally-threaded bores 5164 and 5174 of the first and secondgears 516 and 517, as well as the externally-threaded screws 504 and503, may be oppositely threaded relative to each other. Both screws 503and 504 are fixedly coupled to a top surface 5021 of a thrust plate 502that is positioned between opposite side walls of the housing frame 506.

A staple pusher 514 is attached to a bottom surface of the thrust plate502. The staple pusher 514 includes parallel rows 5141 and 5142 ofdownwardly-disposed teeth 5143, each of which corresponds to and alignswith a staple guide 5053 of the anvil 505. A knife 519 having a cuttingedge 5191 (shown facing downwardly in FIG. 13) is disposed between theparallel rows of downwardly-disposed teeth 5143 of the staple pusher514.

A staple holder or cartridge 513 is disposed below the staple pusher514. The staple cartridge 513 defines vertically-disposed slots 5132,each of which corresponds to and aligns with the downwardly-disposedteeth 5143 of the staple pusher 514 and with the staple guides 5053 ofthe anvil 505. A staple 528 is provided in each slot 5132. The staplecartridge 513 also includes a longitudinally-disposed slot 5131 throughwhich knife 519 may be passed.

A staple retainer 540 is provided and is configured to cover the bottomsurface of the staple cartridge 513 so as to maintain the staples 528within the staple cartridge 513 and to prevent foreign material fromentering the slots 5132 of the staple cartridge 513 during shipping ofend effector 500.

A housing top 510 is provided and is arranged between the opposite sides5062 and 5065 of the housing frame 506 and protects the componentswithin the housing frame 506.

Reference may be made to U.S. patent application Ser. No. 10/094,051(now U.S. Pat. No. 8,016,855), filed on Mar. 8, 2002, entitled “SurgicalDevice”, the entire contents of which are incorporated herein byreference, for a more detailed discussion of the components,construction and operation of end effector 500. In addition, the endeffector is connectable to a powered instrument handle which may includean elongate shaft. A separate, detachable shaft may also be used. Asdisclosed in U.S. Pat. No. 8,016,855, the shaft may be a flexible shaftextending from a housing and detachably attached thereto via a firstcoupling. The distal end of flexible shaft may include a second couplingadapted to detachably attach the end effector described above, to thedistal end of the flexible shaft. The second coupling may also beadapted to detachably attach a different type of end effector. Inanother example embodiment, the distal end of the flexible shaft may bepermanently attached to or be integral with a surgical instrumenthandle.

The shaft may include a first rotatable drive shaft and a secondrotatable drive shaft, such as, for example, braided or helical drivecables. The drive shafts may be configured to transmit low torque buthigh speed, the high-speed/low-torque being converted tolow-speed/high-torque by gearing arrangements disposed, for example, atthe distal end and/or the proximal end of the drive flexible shaft, inthe surgical instrument or attachment. Electro-mechanical driverelements disposed in a remote power console, or in a powered instrumenthandle, are used to operate the rotatable shafts.

In certain preferred embodiments, a controller is provided in thehousing of a remote power console, or in the powered instrument handle,and is configured to monitor and/or control some or all functions andoperations of the end effector attached to the flexible shaft, as wellas the instrument as whole. A memory unit is provided and may includememory devices, such as, a ROM component, a RAM component, etc. The RAMand ROM components are in electrical and logical communication withcontroller via appropriate wiring. Memory units may also communicatewith the controller, or other components, wirelessly.

Turning now to FIGS. 13-16, a more detailed discussion of end effector500, including staple cartridge 513 according to the present disclosure,is provided. As seen in FIGS. 13-16, staple cartridge 513 is segmentedalong an axial length thereof. In particular, staple cartridge 513 isformed from a plurality of individual, separately movable body membersor segments 513 a extending axially along a length of staple cartridge513. Each segment 513 a is free to move in a direction transverse ororthogonal to a plane defined by the tissue contacting surface of staplecartridge 513.

As seen in FIGS. 14-16, slots 5132, for retaining staples 528 therein,are arranged in at least two, longitudinally extending, parallel rowsdisposed on each side of knife slot 5131. The slots 5132 of each pair ofrows are off-set or staggered with respect to one another, wherein theslots 5132 of one row are disposed between the slots 5132 of an adjacentrow.

Each segment 513 a of staple cartridge 513 is axially separated from oneanother by a transverse dividing line 513 b that extends transverselyacross staple cartridge 513 and that does not extend across any stapleslot 5132. In other words, the transverse dividing line 513 b extendsbetween axially adjacent slots 5132. Additionally, each segment 513 a issized so as to include a single slot 5132 from each of the adjacent rowsof slots. However, it is contemplated that more than one slot 5132 fromeach row of slots may be disposed within each segment 513 a.

With continued reference to FIGS. 14-16, end effector 500 furtherincludes a pressure sensing film 526 interposed between staple cartridge513 and sides 5062, 5065 of the housing frame 506. In particular,pressure sensing film 526 includes a plurality of individual pressuresensing film segments 526 a interposed, one each, between respectivesegments 513 a of staple cartridge 513 and sides 5062, 5065 of thehousing frame 506.

As seen in FIG. 13, each segment 513 a of staple cartridge 513 isfloating above respective pressure sensing film segments 526 a byrespective biasing members 513 c, in the form of compression springs. Inparticular, biasing members 513 c are interposed between respectivesegments 513 a of staple cartridge 513 and thrust plate 502 (see FIGS.13 and 16) of end effector 500. In this manner, in use, the gap ordistance from the tissue contacting surface of staple cartridge 513 tothe tissue contacting surface of anvil 505 may adjust or vary dependingon the thickness of tissue clamped between first jaw 580 and second jaw550.

In accordance with the present disclosure, staple cartridge 513 of endeffector 500, when coupled to an intelligent surgical device, instrumentor apparatus 100, as described above, or when coupled to theelectro-mechanical driver system, as shown and described in U.S. patentSer. No. 10/094,051 (now U.S. Pat. No. 8,016,855), filed on Mar. 8,2002, entitled “Surgical Device”, the entire content of which isincorporated herein by reference, is capable of adjusting to accommodatedifferent thicknesses present in a section of tissue that is clampedbetween first jaw 580 and second jaw 550.

Each pressure sensing film segment 526 a is capable of sensing a forcethat is exerted on each segment 513 a of staple cartridge 513 during aclamping or approximation of first jaw 580 and second jaw 550 and/orduring a firing of end effector 500. Each segment 513 a of staplecartridge 513 is spring loaded to a pre-set height, by biasing members513 c, during an unloaded or unclamped condition.

Each pressure sensing film segment 526 a may be in electricalcommunication with the controller 120 (see FIG. 2). In this manner,signals sensed by pressure sensing film segments 526 a may betransmitted to controller 120 for processing and/or analysis, and theprocessed and/or analyzed.

In operation, upon clamping or approximation (i.e., clamp up) of firstjaw 580 and second jaw 550, each segment 513 a of staple cartridge 513becomes individually compressed (i.e., pressed against a respectivepressure sensing film segment 526 a) by the tissue by an amountdependent upon the force exerted on each section 513 a of staplecartridge 513. Due to the floating nature of each segment 513 a ofstaple cartridge 513, each segment 513 a is capable of slight movementin a side-to-side or lateral direction and/or in a longitudinaldirection.

The pressure sensing film segments, in certain embodiments, areconnected to the controller and data are stored in the memory unitsand/or transmitted to other components. The memory units of thecontroller (which may be a remote unit, or may be incorporated in apowered instrument handle attached to the shaft and end effector)include data concerning desired parameters or ranges for the operationof the end effector and instrument as a whole. For example, the forcesexerted on each segment 513 a of staple cartridge 513 is determined bythe pressure sensing film segments 526 a in a manner substantiallysimilar to pressure responsive element 150, as described above. Theforces determined, detected of measured by pressure sensing filmsegments 526 a may be displayed on a monitor, a display provided on thesurgical device, or the like (not shown). It is contemplated that themonitor will display the forces exerted on each individual segment 513 aof staple cartridge 513 as well as the overall force exerted on theentire length of the staple cartridge 513.

The forces measured by the pressure sensing film segments can bemonitored over time. In other words, how the forces vary as the staplesare ejected and formed against the anvil can be monitored, transmittedto the controller, transmitted to other components, stored in the memoryunits of the controller, compared to data concerning desired profilesfor staple forming and/or used to provide information to the surgeon orused to affect the operation of the instrument.

Pressure sensors that can be used include but are not limited toelectrical circuits that measure or monitor differences in one or moreof resistance, conductance, impedance and capacitance. The sensor mayincorporate one or more laminated layers of resistive and conductivesubstrates. Other sensors are contemplated.

In accordance with the present disclosure, the intelligent surgicaldevice, instrument or apparatus 100, as described above, or theelectro-mechanical driver system, as shown and described in U.S. patentapplication Ser. No. 10/094,051 (U.S. Patent Publication No.2003/0130677), will be able to interpret a magnitude of the forces anddetermine whether conditions are acceptable to continueclamping/approximating first jaw 580 and second jaw 550 or if conditionsare acceptable for firing of the end effector 500.

Additionally, in accordance with the present disclosure, the intelligentsurgical device, instrument or apparatus 100, as described above, or theelectro-mechanical driver system, as shown and described in U.S. patentapplication Ser. No. 10/094,051 (U.S. Patent Publication No.2003/0130677), will be able to determine if obstructions are present inthe tissue that is clamped between first jaw 580 and second jaw 550 andwhether conditions are acceptable for firing of end effector 500 basedon the loads and/or forces exerted on staple cartridge 513.

Accordingly, in view of the floating or spring biased nature of staplecartridge 513, and the segments 513 a thereof, an adjustment oraccommodation of staple cartridge 513 is more forgiving in tissues withinconsistent thicknesses, with obstructions and/or which are diseased.Additionally, the force sensing capability of staple cartridge 513 canprovide the surgeon with an indication of the amount of compressiveforce each portion or segment of the tissue is under during aclamping/approximating of the first jaw 580 and second jaw 550 and/orduring a firing of end effector 500. Also, since staple cartridge 513 issegmented and there are a plurality of pressure sensing film segments526 a disposed along an entire length of staple cartridge 513, thesurgeon can be provided with information regarding the presence of anobstruction in the tissue clamped between first jaw 580 and second jaw550 and an indication of the location of the obstruction along thelength of staple cartridge 513.

By providing the surgeon with an indication of the location of theobstruction along the length of staple cartridge 513, the surgeon maymove end effector 500 to another location or section of tissue, ifnecessary, in order to avoid hitting the obstruction during the staplingor firing procedure.

In operation, if the forces exerted on a particular segment 513 a ofstaple cartridge 513 exceed a predetermined threshold value and/or if anaverage force exerted on staple cartridge 513 exceeds a predeterminedthreshold value, then the controller may register an error and may beconfigured to emit an error code, emit a warning and/or stop the firingprocedure.

While several illustrative embodiments of the disclosure have been shownin the drawings, it is not intended that the disclosure be limitedthereto, as it is intended that the disclosure be as broad in scope asthe art will allow and that the specification be read likewise.Therefore, the above description should not be construed as limiting,but merely as exemplifications of preferred embodiments. Thus the scopeof the embodiments should be determined by the appended claims and theirlegal equivalents, rather than by the examples given.

What is claimed is:
 1. A staple cartridge for a surgical staplingapparatus, the stapling apparatus including a first jaw member and asecond jaw member, the first jaw member having a first arm extendingtransversely from a proximal portion thereof, and the second jaw memberhaving a second arm extending transversely from a proximal portionthereof, the first and second arms coupled together to enable movementbetween the first and the second jaw members, the staple cartridgecomprising: opposed outer side surfaces; and a tissue contacting surfacedefining a longitudinal axis that extends between proximal and distalend portions of the tissue contacting surface, the tissue contactingsurface defining a tissue contacting plane and positioned to extenddistally along the longitudinal axis from the arms of the surgicalstapling apparatus when the staple cartridge is coupled to one of thejaw members, the tissue contacting surface including a first segment andat least a second segment, each segment being movable relative to theother segment prior to a firing of the surgical stapling apparatus, eachsegment defining at least two staple receiving slots, each segmentextending between an inner end portion and an outer end portion, theouter end portion of at least one of the segments extending to at leastone of the opposed outer side surfaces of the staple cartridge, thefirst segment floating on a spring and positioned to move from a firstposition aligned with the tissue contacting plane towards a secondposition, the first segment positioned to move towards the spring andaway from the tissue contacting plane as the first segment moves fromthe first position to the second position, wherein the tissue contactingsurface defines a knife slot that extends along the longitudinal axisbetween the proximal and distal end portions thereof, the knife slotseparating the tissue contacting surface into a first side and a secondside, the first segment being disposed on the first side of the knifeslot, the second segment being disposed on the second side of the knifeslot.
 2. The staple cartridge of claim 1, wherein the first position isan expanded position and the second position is a depressed positionrelative to the second segment, wherein the spring is configured to urgethe first segment toward the first position.
 3. The staple cartridge ofclaim 2, further comprising a sensor operatively coupled to at least oneof the first or second segments.
 4. The staple cartridge of claim 3,wherein the sensor is a pressure sensor configured to sense a pressurefrom a movement of at least one of the first or second segments.
 5. Thestaple cartridge of claim 3, wherein the sensor is disposed inelectrical communication with a controller and a power source disposedin the surgical stapling apparatus.
 6. The staple cartridge of claim 1,wherein the at least two staple receiving slots are arranged inlongitudinally extending parallel rows.
 7. The staple cartridge of claim6, wherein the at least two staple receiving slots are staggeredlongitudinally with respect to one another.
 8. The staple cartridge ofclaim 1, wherein at least one of the first or second segments isV-shaped and extends towards the longitudinal axis.
 9. The staplecartridge of claim 1, wherein at least one of the first or secondsegments is movable in at least one of a side-to-side direction and alongitudinal direction relative to the longitudinal axis, theside-to-side direction being transverse to the longitudinal direction.